Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial

Kim Bennell, Elin Wee, Sally Coburn, Sally Green, Anthony Harris, Margaret Staples, Andrew Forbes, Rachelle Buchbinder, Kim Bennell, Elin Wee, Sally Coburn, Sally Green, Anthony Harris, Margaret Staples, Andrew Forbes, Rachelle Buchbinder

Abstract

Objective: To investigate the efficacy of a programme of manual therapy and exercise treatment compared with placebo treatment delivered by physiotherapists for people with chronic rotator cuff disease.

Design: Randomised, participant and single assessor blinded, placebo controlled trial.

Setting: Metropolitan region of Melbourne, Victoria, Australia.

Participants: 120 participants with chronic (>3 months) rotator cuff disease recruited through medical practitioners and from the community.

Interventions: The active treatment comprised a manual therapy and home exercise programme; the placebo treatment comprised inactive ultrasound therapy and application of an inert gel. Participants in both groups received 10 sessions of individual standardised treatment over 10 weeks. For the following 12 weeks, the active group continued the home exercise programme and the placebo group received no treatment.

Main outcome measures: The primary outcomes were pain and function measured by the shoulder pain and disability index, average pain on movement measured on an 11 point numerical rating scale, and participants' perceived global rating of overall change.

Results: 112 (93%) participants completed the 22 week trial. At 11 weeks no difference was found between groups for change in shoulder pain and disability index (3.6, 95% confidence interval -2.1 to 9.4) or change in pain (0.7, -0.1 to 1.5); both groups showed significant improvements. More participants in the active group reported a successful outcome (defined as "much better"), although the difference was not statistically significant: 42% (24/57) of active participants and 30% (18/61) of placebo participants (relative risk 1.43, 0.87 to 2.34). The active group showed a significantly greater improvement in shoulder pain and disability index than did the placebo group at 22 weeks (between group difference 7.1, 0.3 to 13.9), although no significant difference existed between groups for change in pain (0.9, -0.03 to 1.7) or for the percentage of participants reporting a successful treatment outcome (relative risk 1.39, 0.94 to 2.03). Several secondary outcomes favoured the active group, including shoulder pain and disability index function score, muscle strength, interference with activity, and quality of life.

Conclusion: A standardised programme of manual therapy and home exercise did not confer additional immediate benefits for pain and function compared with a realistic placebo treatment that controlled for therapists' contact in middle aged to older adults with chronic rotator cuff disease. However, greater improvements were apparent at follow-up, particularly in shoulder function and strength, suggesting that benefits with active treatment take longer to manifest.

Trial registration: Clinical trials NCT00415441.

Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare (1) RB and KB are partly supported by fellowships from the National Health and Medical Research Council and the Australian Research Council respectively. None of the other authors have financial support for the submitted work from anyone other than their employer; (2) No financial relationships with commercial entities that might have an interest in the submitted work; (3) No spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; (4) No non-financial interests that may be relevant to the submitted work.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787686/bin/benk719567.f1_default.jpg
Fig 1 Flow of participants through study. IQR=interquartile range
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787686/bin/benk719567.f2_default.jpg
Fig 2 Mean (SD) shoulder pain and disability index (SPADI) and pain on movement for active and placebo groups at baseline, 11 weeks, and 22 weeks

References

    1. Chard MD, Hazleman R, Hazleman BL, King RH, Reiss BB. Shoulder disorders in the elderly: a community survey. Arthritis Rheum 1991;34:766-9.
    1. Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, et al. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum 2006;55:765-78.
    1. Badley EM, Tennant A. Changing profile of joint disorders with age: findings from a postal survey of the population of Calderdale, West Yorkshire, United Kingdom. Ann Rheum Dis 1992;51:366-71.
    1. Smith KL, Harryman DT 2nd, Antoniou J, Campbell B, Sidles JA, Matsen FA 3rd. A prospective, multipractice study of shoulder function and health status in patients with documented rotator cuff tears. J Shoulder Elbow Surg 2000;9:395-402.
    1. Bridges-Webb C, Britt H, Miles D, Neary S, Charles J. Morbidity and treatment in general practice in Australia 1990-91. Med J Aust 1992;157:1-56S.
    1. Peters D, Davies P, Pietroni P. Musculoskeletal clinic in general practice: study of one year’s referrals. Br J Gen Pract 1994;44:25-9.
    1. Bartolozzi A, Andreychik D, Ahmad S. Determinants of outcome in the treatment of rotator cuff disease. Clin Orthop Relat Res 1994;308:90-7.
    1. Gartsman GM, Brinker MR, Khan M, Karahan M. Self-assessment of general health status in patients with five common shoulder conditions. J Shoulder Elbow Surg 1998;7:228-37.
    1. Roquelaure Y, Mariel J, Fanello S, Boissiere JC, Chiron H, Dano C, et al. Active epidemiological surveillance of musculoskeletal disorders in a shoe factory. Occup Environ Med 2002;59:452-8.
    1. Ostor AJ, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford) 2005;44:800-5.
    1. Buchbinder R, Goel V, Bombardier C, Hogg-Johnson S. Classification systems of soft tissue disorders of the neck and upper limb: do they satisfy methodological guidelines? J Clin Epidemiol 1996;49:141-9.
    1. Ekeberg OM, Bautz-Holter E, Tveita EK, Juel NG, Kvalheim S, Brox JI. Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study. BMJ 2009;338:a3112.
    1. Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev 2003;2:CD004258.
    1. Lombardi I Jr, Magri AG, Fleury AM, Da Silva AC, Natour J. Progressive resistance training in patients with shoulder impingement syndrome: a randomized controlled trial. Arthritis Rheum 2008;59:615-22.
    1. Glazier RH, Dalby DM, Badley EM, Hawker GA, Bell MJ, Buchbinder R, et al. Management of common musculoskeletal problems: a survey of Ontario primary care physicians. CMAJ 1998;158:1037-40.
    1. Michener LA, McClure PW, Karduna AR. Anatomical and biomechanical mechanisms of subacromial impingement syndrome. Clin Biomech 2003;18:369-79.
    1. Dickens VA. Role of physiotherapy in the treatment of subacromial impingement syndrome: a prospective study. Physiotherapy 2005;91:159-64.
    1. Haahr JP, Ostergaard S, Dalsgaard J, Norup K, Frost P, Lausen S, et al. Exercises versus arthroscopic decompression in patients with subacromial impingement: a randomised, controlled study in 90 cases with a one year follow up. Ann Rheum Dis 2005;64:760-4.
    1. Ludewig PM, Borstad JD. Effects of a home exercise programme on shoulder pain and functional status in construction workers. Occup Environ Med 2003;60:841-9.
    1. Walther M, Werner A, Stahlschmidt T, Woelfel R, Gohlke F. The subacromial impingement syndrome of the shoulder treated by conventional physiotherapy, self-training, and a shoulder brace: results of a prospective, randomized study. J Shoulder Elbow Surg 2004;13:417-23.
    1. Faber E, Kuiper JI, Burdorf A, Miedema HS, Verhaar JA. Treatment of impingement syndrome: a systematic review of the effects on functional limitations and return to work. J Occup Rehabil 2006;16:7-25.
    1. Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg 2009;18:138-60.
    1. Trampas A, Kitisios A. Exercise and manual therapy for the treatment of impingement syndrome of the shoulder: a systematic review. Phys Ther Rev 2006;11:125-42.
    1. Hawkins RJ, Kennedy JC. Impingement syndrome in athletes. Am J Sports Med 1980;8:151-8.
    1. Maitland GD. Vertebral manipulation. Butterworth-Heinemann, 2001.
    1. Bennell K, Coburn S, Wee E, Green S, Harris A, Forbes A, et al. Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: a protocol for a randomised, double-blind, placebo-controlled trial. BMC Musculoskelet Disord 2007;8:86.
    1. Coburn S. Efficacy of physiotherapy for chronic rotator cuff pathology: a randomised, double-blind, placebo controlled pilot trial [masters of physiotherapy thesis]. University of Melbourne, 2008.
    1. Bennell K, Hinman R, Metcalf B, Buchbinder R, McConnell J, McColl G, et al. Efficacy of physiotherapy management of knee joint osteoarthritis: a randomised double-blind placebo-controlled trial. Ann Rheum Dis 2005;64:906-12.
    1. Buchbinder R, Youd JM, Green S, Stein A, Forbes A, Harris A, et al. Efficacy and cost-effectiveness of physiotherapy following glenohumeral joint distension for adhesive capsulitis: a randomized trial. Arthritis Rheum 2007;57:1027-37.
    1. Crossley K, Bennell K, Green S, Cowan S, McConnell J. Physical therapy for patellofemoral pain: a randomized, double-blinded, placebo-controlled trial. Am J Sports Med 2002;30:857-65.
    1. Heald SL, Riddle DL, Lamb RL. The shoulder pain and disability index: the construct validity and responsiveness of a region-specific disability measure. Phys Ther 1997;77:1079-89.
    1. Williams JW Jr, Holleman DR Jr, Simel DL. Measuring shoulder function with the shoulder pain and disability index. J Rheumatol 1995;22:727-32.
    1. Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res 1991;4:143-9.
    1. Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the arm, shoulder, and hand questionnaire (QuickDASH) and numeric pain rating scale in patients with shoulder pain. J Shoulder Elbow Surg 2009;18:920-6.
    1. Ten Klooster PM, Drossaers-Bakker KW, Taal E, van de Laar MA. Patient-perceived satisfactory improvement (PPSI): interpreting meaningful change in pain from the patient’s perspective. Pain 2006;121:151-7.
    1. Walters SJ, Munro JF, Brazier JE. Using the SF-36 with older adults: a cross-sectional community-based survey. Age Ageing 2001;30:337-43.
    1. Hawthorne G, Osborne R. Population norms and meaningful differences for the assessment of quality of life (AQoL) measure. Aust N Z J Public Health 2005;29:136-42.
    1. Osborne RH, Hawthorne G, Lew EA, Gray LC. Quality of life assessment in the community-dwelling elderly: validation of the assessment of quality of life (AQoL) instrument and comparison with the SF-36. J Clin Epidemiol 2003;56:138-47.
    1. Whitfield K, Buchbinder R, Segal L, Osborne RH. Parsimonious and efficient assessment of health-related quality of life in osteoarthritis research: validation of the assessment of quality of life (AQoL) instrument. Health Qual Life Outcomes 2006;4:19.
    1. McNutt LA, Wu C, Xue X, Hafner JP. Estimating the relative risk in cohort studies and clinical trials of common outcomes. Am J Epidemiol 2003;157:940-3.
    1. James KE, Bloch DA, Lee KK, Kraemer HC, Fuller RK. An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation—a VA cooperative study. Stat Med 1996;15:1421-34.
    1. Roy JS, MacDermid JC, Woodhouse LJ. Measuring shoulder function: a systematic review of four questionnaires. Arthritis Rheum 2009;61:623-32.
    1. Kuijpers T, van der Windt DA, van der Heijden GJ, Bouter LM. Systematic review of prognostic cohort studies on shoulder disorders. Pain 2004;109:420-31.
    1. Thomas E, van der Windt DA, Hay EM, Smidt N, Dziedzic K, Bouter LM, et al. Two pragmatic trials of treatment for shoulder disorders in primary care: generalisability, course, and prognostic indicators. Ann Rheum Dis 2005;64:1056-61.
    1. Morton V, Torgerson DJ. Regression to the mean: treatment effect without the intervention. J Eval Clin Pract 2005;11:59-65.
    1. Krogsboll LT, Hrobjartsson A, Gotzsche PC. Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention. BMC Med Res Methodol 2009;9:1.
    1. Barnett AG, van der Pols JC, Dobson AJ. Regression to the mean: what it is and how to deal with it. Int J Epidemiol 2005;34:215-20.
    1. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005;330:1202-5.
    1. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001;344:1594-602.
    1. Crow R, Gage H, Hampson S, Hart J, Kimber A, Thomas H. The role of expectancies in the placebo effect and their use in the delivery of health care: a systematic review. Health Technol Assess 1999;3:1-96.
    1. Ludewig PM, Reynolds JF. The association of scapular kinematics and glenohumeral joint pathologies. J Orthop Sports Phys Ther 2009;39:90-104.
    1. May S, Greasley A, Reeve S, Withers S. Expert therapists use specific clinical reasoning processes in the assessment and management of patients with shoulder pain: a qualitative study. Aust J Physiother 2008;54:261-6.
    1. Cullen D, Breidahl W, Janes G. Diagnostic accuracy of shoulder ultrasound performed by a single operator. Australas Radiol 2007;51:226-9.
    1. Cothran RL Jr. Imaging in evaluating the rotator cuff. J Surg Orthop Adv 2006;15:132-9.
    1. Moosmayer S, Heir S, Smith HJ. Sonography of the rotator cuff in painful shoulders performed without knowledge of clinical information: results from 58 sonographic examinations with surgical correlation. J Clin Ultrasound 2007;35:20-6.
    1. Brox JI, Staff PH, Ljunggren AE, Brevik JI. Arthroscopic surgery compared with supervised exercises in patients with rotator cuff disease (stage II impingement syndrome). BMJ 1993;307:899-903.
    1. Haahr JP, Ostergaard S, Dalsgaard J, Norup K, Frost P, Lausen S, et al. Exercises versus arthroscopic decompression in patients with subacromial impingement: a randomised, controlled study in 90 cases with a one year follow up. Ann Rheum Dis 2005;64:760-4.
    1. Ketola S, Lehtinen J, Arnala I, Nissinen M, Westenius H, Sintonen H, et al. Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome? A two-year randomised controlled trial. J Bone Joint Surg Br 2009;91:1326-34.
    1. Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome. J Orthopaed Sports Phys Ther 2000;30:126-37.
    1. Conroy DE, Hayes KW. The effect of joint mobilization as a component of comprehensive treatment for primary shoulder impingement syndrome. J Orthopaed Sports Phys Ther 1998;28:3-14.
    1. Senbursa G, Baltaci G, Atay A. Comparison of conservative treatment with and without manual physical therapy for patients with shoulder impingement syndrome: a prospective, randomized clinical trial. Knee Surg Sports Traumatol Arthrosc 2007;15:915-21.
    1. Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ 2009;338:b2393.

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